A Study to Evaluate the Tolerability, Safety, and PK of AST-201 in Patients With GPC3-positive Advanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age19+
SponsorAptamer Sciences, Inc.
About this trial
This is the first in human trial clinical study of AST-201 in patients with GPC3-positive advanced solid tumors. This study aims to evaluate the safety, tolerability, pharmacokinetic properties, and preliminary efficacy of AST-201 across various tumor types.
Eligibility criteria
Qualifiers
Male and female aged ≥19 years
Histologically and/or cytologically diagnosed as the advanced recurrent solid tumor
GPC3-positive confirmed by IHC test
At least 1 measurable or non-measurable but evaluable lesion as defined per RECIST v1.1 (modified RECIST for hepatocellular carcinoma)
Disqualifiers
Subjects with ischemic heart disease
Subjects with anti-tumor treatment within 4 weeks
Subjects with comorbidities such as uncontrolled hypertension, heart failure, etc.
Pregnant or potentially pregnant and lactating woman
Trial design
Treatments tested in this trial
- AST-201
Treatment groups
70 Participants
are divided into 1 treatment groupSponsors and collaborators
Aptamer Sciences, Inc.
Lead sponsor
CHA University
Collaborator
National Cancer Center, Korea
Collaborator
Samsung Medical Center
Collaborator
Severance Hospital
Collaborator
Source ClinicalTrials.gov